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PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
This study has been completed.
First Received: April 8, 2005   Last Updated: September 7, 2007   History of Changes
Sponsor: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00107848
  Purpose

The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep apnea/hypopnea), when administered for up to 12 months. Safety and tolerability will be evaluated throughout the study by means of adverse event information, clinical laboratory test results, vital signs measurements, and body weight and height measurements; quarterly physical examination findings; and 12 lead electrocardiograph (ECG) evaluations at the end of the study. In addition, the cognitive and behavioral effects of PROVIGIL will be assessed quarterly as measured by the Child Behavior Checklist for Ages 6-18 (CBCL/6-18), a brief psychiatric interview, and the Kaufman Brief Intelligence Test (KBIT 2).


Condition Intervention Phase
Narcolepsy
Sleep Apnea, Obstructive
Drug: Modafinil
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A 1 Year Open Label, Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

Resource links provided by NLM:


Further study details as provided by Cephalon:

Primary Outcome Measures:
  • The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS, when administered for up to 12 months.

Secondary Outcome Measures:
  • The secondary objective of the study is to evaluate long-term effectiveness by using: the Clinical Global Impression of Change (CGI C) ratings for severity of ES and the total score from the Pediatric Daytime Sleepiness Scale (PDSS)

Estimated Enrollment: 280
Study Start Date: October 2004
Estimated Study Completion Date: September 2005
Detailed Description:

PROVIGIL is a registered trademark of Genelco, S.A., licensed to Cephalon, Inc.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Appropriate written assent is obtained from the patient and written informed consent is obtained from the parent or legal guardian (defined by the IEC/IRB)
  • A boy or girl aged 6 through 16 years (at the start of the previous double blind study), inclusive, who participated in study C1538/3027/NA/MN or C1538/3028/AP/MN
  • Have a diagnosis (as established in the previous double blind study) of narcolepsy (or presumed narcolepsy) or OSAHS according to the criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM)
  • Continue to be in good health as determined by a medical and psychiatric history, ECGs, physical examination findings, serum chemistry, hematology, and urinalysis
  • Have blood pressure values greater than those for the 5th percentile and less than the 95th percentile on the National High Blood Pressure Education Program guidelines for blood pressure levels for boys and girls ages 6 through 16 years
  • Girls who are post menarche or sexually active who have a negative urine pregnancy test at the screening/baseline visit, must be using a medically acceptable method of birth control, and must agree to continued use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptives (oral, topical [patch], implanted, and injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence
  • No positive urine drug screen (UDS) for any illicit drug or alcohol (ethanol) at baseline visit, unless a false positive is suspected, in which case the UDS will be repeated. If the patient has a positive drug screen for methylphenidate or amphetamine at screening, the patient must have a negative UDS after a washout period and prior to baseline.
  • Have a parent or legal guardian who is willing to participate in the study
  • Continue to meet inclusion criteria from the previous study, as appropriate

Exclusion Criteria:

  • Have self induced sleep deprivation/poor sleep hygiene
  • Have a past or present seizure disorder (except history of a single febrile seizure), a history of psychosis, or of clinically significant head trauma (eg, brain damage) or past neurosurgery
  • Have a history of suicide attempt, or are at suicidal risk
  • A clinically significant drug sensitivity to stimulants such as amphetamine, dextroamphetamine, methylphenidate, or pemoline; and modafinil or any of its components
  • Any disorder that could interfere with drug absorption, distribution, metabolism, or excretion (including previous gastrointestinal surgery)
  • Active, clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other major clinically significant disorder/disease
  • Any clinically significant deviation from the normal range(s) in the ECG or physical examination findings, or clinical laboratory (ie, hematology, serum chemistry, urinalysis) test results at the screening/baseline visit
  • Absolute neutrophil count (ANC) below the lower limit of normal at the baseline visit (NOTE: If the ANC is below the lower limit of normal at the baseline visit, the medical monitor will be consulted for continued eligibility in the study.)
  • A seated pulse outside the range of 60 through 115 bpm after resting for 5 minutes
  • A total daily intake of more than 500 mg of caffeine per day (eg, approximately ten 12 ounce caffeinated sodas, 5 cups of coffee or tea, or about 25 ounces of chocolate per day) within 1 week of the baseline visit
  • Pregnant or lactating/nursing; any child who becomes pregnant during the study will be withdrawn.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107848

  Hide Study Locations
Locations
United States, Alabama
Chris M. Makris, M.D.
Birmingham, Alabama, United States, 35233
Robert Doekel, Jr., M.D.
Birmingham, Alabama, United States, 35213
United States, Arizona
Barbara Harris, Ph.D.
Phoenix, Arizona, United States, 85050
Derek Loewy, Ph.D.
Tucson, Arizona, United States, 85712
United States, Arkansas
Joseph McCarty, M.D.
Fort Smith, Arkansas, United States, 72913
Samuel Boellner, M.D.
Little Rock, Arkansas, United States, 72205
United States, California
Jed Black, M.D.
Stanford, California, United States, 94305
Julie Thompson-Dobkin, D.O.
Huntington Beach, California, United States, 92648
Lawrence Sher, M.D.
Rolling Hills Estates, California, United States, 90274
Mark Buchfuhrer, M.D.
Long Beach, California, United States, 90806
Milton K. Erman, M.D.
San Diego, California, United States, 92121
Stuart Menn, M.D.
Palm Springs, California, United States, 92262
Yury Furman, M.D.
Los Angeles, California, United States, 90048
United States, Connecticut
Edward O'Malley
Norwalk, Connecticut, United States, 06856
United States, Florida
Americo Padilla, M.D.
Miami, Florida, United States, 33173
Martin A. Cohn, M.D.
Naples, Florida, United States, 34110
Elias H. Sarkis
Gainesville, Florida, United States, 32607
United States, Georgia
Charles Wells, Jr., M.D.
Macon, Georgia, United States, 31208
D. Alan Lankford, Ph.D.
Atlanta, Georgia, United States, 30342
Joel Greenberg
Savannah, Georgia, United States, 31405
Jerry Silverboard, M.D.
Atlanta, Georgia, United States, 30342
Robert M. Cohen
Stockbridge, Georgia, United States, 30281
Gary Montgomery, M.D.
Atlanta, Georgia, United States, 30342
United States, Illinois
Michael Kohrman, M.D.
Chicago, Illinois, United States, 60637
Stephen H. Sheldon, D.O., FAAP
Chicago, Illinois, United States, 60614
United States, Indiana
James Cook, M.D.
Danville, Indiana, United States, 46122
United States, Kansas
William Leeds, D.O.
Topeka, Kansas, United States, 66606
United States, Kentucky
Karen Waters, M.D.
Louisville, Kentucky, United States, 40202
United States, Louisiana
Margaret Ann Springer, M.D.
Shreveport, Louisiana, United States, 71103
United States, Maryland
Helene A. Emsellem, M.D.
Chevy Chase, Maryland, United States, 20815
Marc Raphaelson
Frederick, Maryland, United States, 21702
United States, Michigan
George Zureikat, M.D.
Flint, Michigan, United States, 48503
United States, Mississippi
John Harsh, Ph.D., DABSM
Hattiesburg, Mississippi, United States, 39401
United States, Nevada
William Torch, M.D., MS
Reno, Nevada, United States, 89502
United States, New Jersey
Monroe Karetzky, M.D.
Newark, New Jersey, United States, 07112
Lee Brooks, M.D.
Princeton, New Jersey, United States, 08540
Marc Seelagy, M.D.
Trenton, New Jersey, United States, 08629
Kathleen Ryan, M.D.
Mount Laurel, New Jersey, United States, 08054
United States, New York
Gary Zammit, M.D.
New York, New York, United States, 10025
United States, Ohio
Michael Neeb, Ph.D.
Toledo, Ohio, United States, 43608
Ramalinga Reddy
Toledo, Ohio, United States, 43608
Carol Rosen
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Jorg Pahl, M.D.
Oklahoma City, Oklahoma, United States, 73118
William C. Orr, Ph.D.
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
Judith Owens, M.D., MPH
Providence, Rhode Island, United States, 02903
United States, South Carolina
Richard Bogan, M.D., FCCP
Columbia, South Carolina, United States, 29201
United States, Tennessee
Julie Jacques, D.O.
Morristown, Tennessee, United States, 37814
United States, Texas
David Sperry, M.D.
Dallas, Texas, United States, 75230
Jerry J. Tomasovic, M.D.
San Antonio, Texas, United States, 78258
John Hudson, M.D.
Austin, Texas, United States, 78756
Todd J. Swick, M.D.
Houston, Texas, United States, 77024
United States, Utah
James M. Ferguson, M.D.
Salt Lake City, Utah, United States, 84107
Radiant Research, Salt Lake City
Salt Lake City, Utah, United States, 84107-7591
United States, Virginia
James Perlstrom
Fairfax, Virginia, United States, 22030
United States, Washington
Robert J. Reichler
Seattle, Washington, United States, 98133
Canada, Alberta
Adam Moscovitch, M.D.
Calgary, Alberta, Canada, T2X2A8
Manisha Witmans
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Colin Shapiro, Ph.D.
Toronto, Ontario, Canada, M5T2S8
Lawrence Reinish
Parry Sound, Ontario, Canada, P2A 3A4
Mortimer Mamelak, M.D.
Toronto, Ontario, Canada, M2J2K9
Leonid Kayumov, M.D.
Scarborough, Ontario, Canada, M1S1T7
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

Study ID Numbers: C1538/3029/ES/MN-Open label
Study First Received: April 8, 2005
Last Updated: September 7, 2007
ClinicalTrials.gov Identifier: NCT00107848     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Cephalon:
Pediatric Narcolepsy
Pediatric OSA
CPAP
Pediatric Narcolepsy or OSAHS

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Physiological Effects of Drugs
Sleep Disorders
Disorders of Excessive Somnolence
Neuroprotective Agents
Modafinil
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Narcolepsy
Mental Disorders
Syndrome
Therapeutic Uses
Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Disease
Apnea
Respiration Disorders
Nervous System Diseases
Dyssomnias
Central Nervous System Stimulants
Protective Agents
Pharmacologic Actions
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009